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Showing 15 posts of 1442 posts found.

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FDA committee recommends Kynamro

October 23, 2012
Research and Development, Sales and Marketing FDA, Genzyme, Kynamro, Sanofi

Sanofi’s anti-cholestrol drug Kynamro has been recommended by an FDA committee, paving the way for US approval early next year. …

News

FDA approves Bayer’s Stivarga

October 1, 2012
Research and Development, Sales and Marketing Bayer, FDA, KRAS, Roche, Stivarga, avastin

The FDA has approved Bayer HealthCare’s oncology pill Stivarga to treat patients with metastatic colorectal cancer (mCRC) whose disease has …

News

New quad HIV pill passed by FDA

September 2, 2012
Sales and Marketing FDA, Gilead, HIV, stribild

Gilead’s four-in-one anti-HIV once-daily pill Stribild has been given the green light by the FDA for adults who have not …

News

GMP certification bodes well for Alexza’s lead product

August 28, 2012
Manufacturing and Production Alexza, FDA, GMP, schizophrenia

US drugmaker Alexza Pharmaceuticals’ manufacturing facility for lead product Adasuve has been given a green light from the Spanish medicine …

News

Pfizer’s arthritis drug delayed by FDA

August 21, 2012
Research and Development, Sales and Marketing FDA, Pfizer, tofacitinib

Pfizer says its new rheumatoid arthritis drug tofacitinib has been delayed by the FDA. Tofacitinib, an oral Janus kinase (JAK) …

News

Claris LifeSciences gets clean bill of health from FDA

August 20, 2012
Manufacturing and Production, Sales and Marketing Claris, FDA, Pfizer, sterile

Indian drugmaker Claris LifeSciences seems to have set its house in order after manufacturing issues led the FDA to impose …

News
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Novartis eye drug succeeds in Phase III trial

August 16, 2012
Sales and Marketing FDA, Novartis, Ocriplasmin, Roche, VMA

Novartis has posted positive results for its investigational eye drug ocriplasmin. The Phase III study found that ocriplasmin significantly resolved …

News
Nexium image

Pfizer pays $250m for OTC Nexium rights

August 14, 2012
Sales and Marketing AstraZeneca, EMA, FDA, Nexium, OTC, Pfizer

Pfizer will pay $250 million to AstraZeneca in order to gain the rights to sell an over-the-counter form of the …

News
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Lucentis gains new licence in the US

August 13, 2012
Sales and Marketing Eylea, FDA, Lucentis, approval, avastin, wet AMD

Roche’s eye drug Lucentis has gained a new licence in the US to treat diabetic macular oedema. The FDA has …

News
FDA image

FDA approves leukaemia drug Marqibo

August 10, 2012
Sales and Marketing FDA, Marqibo, Talon Therapeutics, lilly

The Food and Drug Administration has given the green light for Talon Therapeutics’ Marqibo to combat a rare form of …

News

Pfizer pays $60m in bribery cases

August 8, 2012
Sales and Marketing DoJ, FDA, GSK, Janssen, Pfizer, Wyeth, bribery

Pfizer has been fined $60 million for making improper payments to doctors in Europe, Asia and the Middle East. The …

News
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Champix better than patches for smoking cessation

August 7, 2012
Sales and Marketing Champix, FDA, Pfizer, Zyban, smoking

New research shows that Pfizer’s Champix is better than nicotine patch therapy at helping smokers kick the habit. A Pfizer …

News

Sanofi’s colorectal cancer drug gains FDA approval

August 6, 2012
Sales and Marketing FDA, Sanofi, Zaltrap, colorectal cancer

The FDA has approved Sanofi and Regeneron’s new oncology drug Zaltrap for aggressive forms of colorectal cancer.Zaltrap (ziv-aflibercept), in combination …

News
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GSK submits melanoma drugs for regulatory approval

August 3, 2012
Sales and Marketing FDA, GSK, NDA, Zelboraf, melanoma, oncology

GlaxoSmithKline has submitted its two investigational melanoma drugs to regulators in both Europe and the US. The firm is seeking …

News

Pfizer’s RA pill impresses in Phase III

August 1, 2012
Research and Development, Sales and Marketing FDA, JAK, Pfizer, RA

Pfizer’s investigational arthritis drug tofacitinib has beaten methotrexate in a head-to-head study. Tofacitinib, an oral Janus kinase (JAK) inhibitor, is …

News
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